What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Fiber, or Placebo. The registry lists allocation as randomized. This study is a neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment study that evaluates the whether it is safe and how hard side effects are to live with of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks.
They plan to enroll about 140 people at San Francisco. Taking part typically means study visits and measurements plus check-ins.
Official title (unrewritten)
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Mechanistic Effects of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) on the Gut and Vaginal Microbiome, Gastrointestinal Well-Being, and Quality-of-Life Parameters in Women With Endometriosis and Co-Existing Gastrointestinal Symptoms
Interventions: Fiber, Placebo
Primary outcome (registry wording): Incidence and severity of GI adverse events (AEs) and discontinuations.